The objective was to investigate a possible drug-drug interaction between BI 10773 and metformin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and metformin were determined when both drugs were given in combination compared with BI 10773 or metformin given alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 7 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 7 days
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose) of BI 10773
Time frame: up to 7 days
C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose) of metformin
Time frame: up to 7 days
λz,ss (terminal half-life of the analyte in plasma)
Time frame: up to 7 days
t½,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 7 days
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 7 days
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: up to 7 days
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: up to 7 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
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Time frame: up to 7 days
Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
CLR,ss (renal clearance of the analyte at steady state) of BI 10773 and metformin
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
Urinary glucose excretion (UGE)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
Number of patients with abnormal findings in physical examination
Time frame: Baseline and within 3-14 days after last study drug administration
Number of patients with clinically significant changes in vital signs (Blood Pressure, Pulse Rate)
Time frame: Baseline, day 1 and within 3-14 days after last study drug administration
Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)
Time frame: Baseline and within 3-14 days after last study drug administration
Number of patients with abnormal changes in clinical laboratory tests
Time frame: Baseline, day 1, 4, 5 and within 3-14 days after last study drug administration
Number of patients with adverse events
Time frame: up to 40 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Within 3-14 days after last study drug administration